Active — Not RecruitingEarly Phase 1

Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Greece80 participantsStarted 2021-09-24

Plain-language summary

Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age under 37 weeks * Premature newborns hospitalised in the NICU for at least eight days * (for parents) be able to speak and read Greek or English Exclusion Criteria: * Newborns with congenital and chromosomal abnormalities. * Newborns with severe accompanying pathological problems and congenital infections. * (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The neonatal behavioural assessment scale (NBAS)

Timeframe: newborn - 2 month old (corrected age)

The New-born Behavioral Observations (NBO)

Timeframe: Βirth through the 3rd month of life

The Qualitative Assessment of General Movements (GMsA)

Timeframe: birth to 20 weeks (corrected age)

• Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)

Timeframe: Birth to 12 months

• Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)

Timeframe: From Enrollment to the end of interventional 3 months

Trial details

NCT IDNCT05565287

SponsorUniversity of Thessaly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Neonatal Disease trials